Brad Rust Email & Phone Number

Greenfield, In

Provide technical support and oversight for established products managed by the Elanco External Manufacturing - North America organization, ensuring a reliable supply of quality products at minimum cost. Partner with R&D, supply chain, launch leaders and quality throughout the commercialization and launch of new products.

Greenfield, In

Continuation of legacy Novartis Global Product Steward position activities under Elanco, Inc.

Greensboro/Winston-Salem, North Carolina Area

- Ensured oversight of technical and quality aspects for pharmaceutical drug products in scope, end to end from product launch to product phase out across the entire supply chain and multiple sites. - Maintained and improved product process capability, quality and compliance.- Single point of contact and the subject matter expert for all technical aspects around a product or products.- Led interdisciplinary Technical Product Stewardship Team and defined project priorities (project… Show more - Ensured oversight of technical and quality aspects for pharmaceutical drug products in scope, end to end from product launch to product phase out across the entire supply chain and multiple sites. - Maintained and improved product process capability, quality and compliance.- Single point of contact and the subject matter expert for all technical aspects around a product or products.- Led interdisciplinary Technical Product Stewardship Team and defined project priorities (project manager). As a member of the Brand/Category product team, establish a link to Marketing and align on project priorities.- Ensured processes are in a constant state of validation and compliance end to end, across multiple sites including process, packaging and analytical.- Initiated continuous improvement projects – quality and cost – to get and keep products in control and lead the projects, proactively interfacing with the relevant functions involved (QA, Regulatory (US and ROW), CMC, Analytics, Technical Development, R&D). Develop project plans to track and focus the projects.- Developed continuous process verification (validation process life cycle stage 3) with third party manufacturing site.- Contributed to and review of Annual Product Reviews/Product Quality Reviews.- Led interdisciplinary teams for timely root cause investigations for significant or recurring deviations, OOS/OOE/OOTs and technical customer complaints and subsequently identified any systemic issues.- Provided answers to technical questions to internal inspection bodies or to Health authorities.- Led manufacturing, packaging and analytical technical transfers from site to site. Show less

- For global products, insured the products are formulated and packed on time, with adequate quality, in full compliance with optimized operating costs through their life-cycle.- Selected manufacturing and packaging sites within Novartis or with third parties in line with the Novartis strategy and corporate guidelines.- Led projects within the team.- Provided technical support to third party manufacturing site following voluntary shutdown and restart of NAH products.- Worked… Show more - For global products, insured the products are formulated and packed on time, with adequate quality, in full compliance with optimized operating costs through their life-cycle.- Selected manufacturing and packaging sites within Novartis or with third parties in line with the Novartis strategy and corporate guidelines.- Led projects within the team.- Provided technical support to third party manufacturing site following voluntary shutdown and restart of NAH products.- Worked with logistics and planning to insure product avaliability and on time delivery.- Monitored and optimized production costs, reduces supply chain complexity, maintains product quality and compliance. Show less

Greensboro/Winston-Salem, North Carolina Area

- Worked directly with contract manufacturers and packagers supplying NAH products to provide technical product support including optimization, process improvements, packaging changes, productivity improvements, etc. on new and existing drug products.- Developed oral solid dose formula, process as well as packaging requirements for new product dose/strength.- Ensured that all manufacturing/packaging process changes and studies for new or commercialized products are executed and… Show more - Worked directly with contract manufacturers and packagers supplying NAH products to provide technical product support including optimization, process improvements, packaging changes, productivity improvements, etc. on new and existing drug products.- Developed oral solid dose formula, process as well as packaging requirements for new product dose/strength.- Ensured that all manufacturing/packaging process changes and studies for new or commercialized products are executed and documented through the change control process. - Coordinated with the production planner and the manufacturing/packaging site to insure adequate supply of inventory.- Worked with third parties (manufacturing, packaging and analytical) on project budgets - Managed the transfer of a liquid solid dose product. Wrote the CMC change submission.- Participate in new projects as a member of the International Product Team/New Product Team. - Effectively communicated with the IPT/NPT critical information regarding the project.- Led transfer project teams, project change teams, analytical transfer teams. Utilize Concerto as a project management tool to track activities related to the projects.- Reviewed and approved manufacturing, packaging and analytical investigations. Show less

Greensboro/Winston-Salem, North Carolina Area

- Worked directly with contract manufacturers, managing manufacturing process optimization, scale up, and registration manufacturing for animal health drug products. - Provided technical commercial support to R&D for commercialization of a new pain injectable product.- Evaluated the overall changes in manufacturing through change control management and their review the impact on regulatory.- Established and maintained effective contract manufacturing relationships to support the… Show more - Worked directly with contract manufacturers, managing manufacturing process optimization, scale up, and registration manufacturing for animal health drug products. - Provided technical commercial support to R&D for commercialization of a new pain injectable product.- Evaluated the overall changes in manufacturing through change control management and their review the impact on regulatory.- Established and maintained effective contract manufacturing relationships to support the development, registration and commercialization of existing drug products.- Evaluated potential suppliers by assessing their abilities to support scale up and transfer, registration and commercial manufacturing of both new and existing drug products. Transferred multiple products including a solid dose product from a Canadian site to a non FDA approved European. Worked with the site to submit and become FDA approved.- Coordinate all manufacturing and packaging activities at the contract manufacturing site through a strong knowledge base of cGMPs, validation requirements and compliance standards.- Prepared and kept yearly project budgets.- Worked directly with the manufacturing sites, packaging sites and analytical sites reviewing and approving process/analytical investigations.- Developed new product packaging design artwork. Show less

Responsible for all technical aspects of assigned products, both internally and at third parties (produced on site), including product transfers, validations, line extensions, investigations, general cGMP documentation, annual product reviews, equipment, raw material suitability and product development work.- Investigated an oral solid dose products high reject rates and developed a solution resulting in an annual projected yield savings of approximately $121,000 as well as elimination… Show more Responsible for all technical aspects of assigned products, both internally and at third parties (produced on site), including product transfers, validations, line extensions, investigations, general cGMP documentation, annual product reviews, equipment, raw material suitability and product development work.- Investigated an oral solid dose products high reject rates and developed a solution resulting in an annual projected yield savings of approximately $121,000 as well as elimination of related batch rejects at $3.3M over the previous three years.- Developed the formula and process for a new oral solid dose product strength. Developed and executed the project plan to advance the project to the commercial phase including regulatory submission documentation.- Technical lead for multiple product transfers to the site.- Technical lead for multiple product process validations, both liquid and oral solid dose. Show less

Perform analytical testing on pharmaceutical products, troubleshoot HPLC and general lab instrumentation, and comply with all cGMPs and federal regulations. Check and validate analyst laboratory work and notebooks, train analysts. Check batch tickets and release product to packaging.

Ba, Biochemistry

Aas, Environmental Lab Technology

Studies inlcuded Chemistry, Analytical Chemistry, Biochemistry, Biology, General Microbiology, Food Microbiology, Water and Wastewater.